Sildenafil Effect After Ovulation Induction

NCT ID: NCT02890238

Last Updated: 2019-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2019-12-31

Brief Summary

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100 women with infertility classified into 2 groups.

Group A: Included 50 women who will be given clomiphene citrate 50mg (clomid) orally 2 times/day from 2rd-7th day of the cycle and sildeaynafil citrate 20mg tab from 7th-11th day of the same cycle orally 3 times/day.

Group B: Included 50 women who will be given clomiphene citrate 50mg (clomid) orally 2 times/day from 2rd-7th day of the cycle and placebo tablets from 7th-11th day of the same cycle orally 3 times/day.

Detailed Description

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100 women with infertility classified into 2 groups.

Group A: Included 50 women who will be given clomiphene citrate 50mg (clomid) orally 2 times/day from 2rd-7th day of the cycle and sildeaynafil citrate 20mg tab from 7th-11th day of the same cycle orally 3 times/day.

Group B: Included 50 women who will be given clomiphene citrate 50mg (clomid) orally 2 times/day from 2rd-7th day of the cycle and placebo tablets from 7th-11th day of the same cycle orally 3 times/day.

Folliculometry was assessed by:

* Transvaginal ultrasound: It was done on day 11th of the cycle to detect number of follicles and endometrial thickness.

When the follicles reach ≥18 ml, injection of 5000 IU of HCG IM to trigger ovulation to both groups.

Pregnancy was assessed by:

* Beta HCG test: (Radioimmunoassay)

Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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sildenafil citrate

50 women who will be given clomiphene citrate 50mg (clomid,) orally 2times/day from 2rd - 7th day of the cycle and sildenafil citrate 20mg tab from 7th-11th day of the same cycle orally 3times/day

Group Type ACTIVE_COMPARATOR

Clomiphene citrate

Intervention Type DRUG

50mg (clomid,) orally 2 times/day from 2nd- 7th day of the cycle

sildenafil citrate

Intervention Type DRUG

20mg tab from 7th-11th day of the same cycle orally 3times/day

placebo group

50 women who will be given clomiphene citrate 50mg (clomid,) orally 2times/day from 2rd- 7th day of the cycle and placebo tablets from 7th-11th day of the same cycle orally 3 times/day

Group Type PLACEBO_COMPARATOR

Clomiphene citrate

Intervention Type DRUG

50mg (clomid,) orally 2 times/day from 2nd- 7th day of the cycle

Placebo

Intervention Type DRUG

tab from 7th-11th day of the same cycle orally 3times/day

Interventions

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Clomiphene citrate

50mg (clomid,) orally 2 times/day from 2nd- 7th day of the cycle

Intervention Type DRUG

sildenafil citrate

20mg tab from 7th-11th day of the same cycle orally 3times/day

Intervention Type DRUG

Placebo

tab from 7th-11th day of the same cycle orally 3times/day

Intervention Type DRUG

Other Intervention Names

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clomid Viagra

Eligibility Criteria

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Inclusion Criteria

1. Infertile women whether it's primary or secondary infertility
2. Woman's age: (18-35 years old)
3. Menstrual cycle from (24-35 days)
4. Normal semen analysis

Exclusion Criteria

1. Age more than 35 years old
2. Ovarian cysts
3. Abnormal hormonal profile (e.g hyperprolactinaemia)
4. Significant cardiovascular disease
5. Serious liver disease or renal failure
6. Poorly controlled diabetes mellitus
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed M Maged, MD

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed Maged

Role: PRINCIPAL_INVESTIGATOR

Kasr Alainy medical school

Locations

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Kasr Alainy medical school

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Ahmed Maged

Role: CONTACT

01005227404

Facility Contacts

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Ahmed Maged, MD

Role: primary

01005227404

Other Identifiers

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156

Identifier Type: -

Identifier Source: org_study_id

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